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Rapid point-of-care detection of Chlamydia trachomatis in urine

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AI155266-01A1
Agency Tracking Number: R41AI155266
Amount: $149,920.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIAID
Solicitation Number: PA20-265
Solicitation Year: 2020
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-04-22
Award End Date (Contract End Date): 2022-03-31
Small Business Information
Placentia, CA 92870-1731
United States
DUNS: 080871816
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: Yes
Principal Investigator
 (657) 226-5977
Business Contact
Phone: (657) 226-5977
Research Institution
LOS ANGELES, CA 90095-9000
United States

 Nonprofit College or University

Project Summary
The goal of this project is to demonstrate feasibility of a system for the point-of-care (POC) detection of
Chlamydia trachomatis (CT) in human urine samples that integrates a patented detector of pathogens based on
identification of species-specific, nucleic acid (NA) sequences. The detector relies on a novel electromechanical
signal transduction mechanism that enables the low-cost, optics-free and amplification-free (e.g., no PCR)
detection of DNA/RNA at ultralow concentration (~10-19 M). A compelling need persists for rapid (minutes), cost
effective, POC NA detection devices for infectious disease diagnostics so as to facilitate prompt, well-informed
therapies and counseling and to avoid potentially harmful actions including the inappropriate prescription of
antibiotics. In earlier work, we demonstrated the detection of Neisseria gonorrhoeae (NG), a CDC top-three
public health threat, with sensitivity of ~98% and specificity of ~100%. Chlamydia, the most common notifiable
disease in the US, is most often tested for in parallel with NG and is therefore the next most logical target for us
to address. A key feature of the patented detector is the use of peptide nucleic acid (PNA) capture probes, which
are uncharged polyamide analogs to NAs that share the same base chemistry. Since bead-PNA conjugates are
designed to be charge neutral, they do not exhibit electrophoretic movement in the presence of a DC electric
field. However, the substantial negative charge acquired upon capture of a target NA sequence makes the
hybridized conjugate mobile. Electrophoresis of the bead-PNA conjugate with hybridized target NA to the mouth
of a smaller diameter glass pore causes a significant increase in pore resistance, thereby resulting in a strong,
sustained drop in measured ionic current. Nonspecifically bound NA is removed from the bead conjugate in the
strong electric field in the pore mouth resulting in no sustained signal. Further, the opposing electroosmotic flow
through the glass pore sweeps PNA-bead conjugates without hybridized target away from the pore mouth. In
such a way, this simple conductometric device gives a highly selective (no observed false positives), binary
response signaling the presence or absence of the target NA (and associated pathogen). This project focuses
on two Aims: 1) Demonstration of the detection of CT in remnant urine samples from the UCLA Clinical
Microbiology Laboratory with competitively high sensitivity (≥95%) and specificity (≥95%) and 2) Development
and feasibility testing of key steps in an integrated and robust prototype device for rapid (andlt;5 mins) bacterial
detection based on the use of magnetic beads that minimizes the need for multiple chambers, pumps and valves.
Successful achievement of these Aims will result in a device concept ready for prototype development that is
capable of NG and CT testing with competitive accuracy and likely with significant advantages of cost, rapidity,
power and robustness. Further research and development work is envisioned to expand sampling capabilities
to other pathogens, both microbial and viral, and to other complex sample media including blood and sputum.Project Narrative
The goal of this project is to demonstrate feasibility of a system for the point-of-care detection of chlamydia in
human urine samples that integrates a patented detector of pathogens based on nucleic acid sequences. The
device addresses the projected $12.8B disease diagnostics market and is directed at the acute need for practical,
point-of-care diagnostic devices. Successful achievement of the specific project goals will constitute significant
progress toward a prototype microfluidic system for detection of gonorrhea and chlamydia in human urine.

* Information listed above is at the time of submission. *

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